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Health Canada Grants Full Approval of Sativex For the Treatment of Spasticity Due to Multiple Sclerosis
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Health Canada Grants Full Approval For GW Pharmaceuticals For Medical Use of Sativex For the Treatment of Spasticity Due to Multiple Sclerosis
August 31st 2010
Porton Down, UK; Toronto, Canada – August 31, 2010 – GW Pharmaceuticals plc (AIM: GWP) and Bayer Inc., a subsidiary of Bayer AG, today announced that Health Canada has approved Sativex? [delta-9-tetrahydrocannabinol 27 mg/mL (from Tetrabinex? – cannabis sativa L. extract) and cannabidiol 25 mg/mL (from Nabidiolex? – cannabis sativa L. extract)] as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS). Sativex? is the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant containing both delta-9-tetrahydrocannabinol and cannabidiol. This means that people in Canada with MS experiencing the debilitating symptoms of spasticity, such as painful spasms and cramps, will now have a new treatment option in addition to standard therapy.
The MS spasticity indication has received a full marketing authorization, or Notice of Compliance (NOC), from Health Canada. Sativex? is useful as adjunctive treatment for symptomatic relief of spasticity in adult patients with MS who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy. In addition to this new NOC, Health Canada approved Sativex? in 2005 under its Notice of Compliance with Conditions (NOC/c) policy as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis, and granted a further NOC/c approval in 2007 as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.1
"Health Canada’s approval of a third indication for Sativex? demonstrates the broad applications of this medicine," said Dr. Shurjeel Choudhri, Chief Medical Officer and Head, Medical and Scientific Affairs, Bayer Inc. "Sativex? meets a significant unmet medical need by improving the symptoms of spasticity in patients with MS who have failed to respond to current anti-spasticity medication. We believe that this approval represents an important step forward in the available treatment options for the MS patient population in Canada."
Dr Stephen Wright, R&D Director, GW, said: "Following recent approvals in the UK and Spain, Canada is now the third major country to approve Sativex? for symptomatic relief of spasticity in adult patients with MS. This regulatory approval has come several months earlier than anticipated and GW looks forward to working with Bayer to develop the marketing strategy for this new indication. We are delighted that the international regulatory program for Sativex? is continuing its positive momentum."
http://www.gwpharm.com/Health%20Canada%20Grants%20Full%20Approval%20of%20Sativex%20For%20the%20Treatment%20of%20Spasticity%20Due%20to%20Multiple%20Sclerosis.aspx
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